Biol 518: Presentations 4-02-03

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Presentation on Stem Cell Research 4/2/03
Stem Cell Legislation & Ethics
Karen

Early Stem Cell Legislation

1996 - Dickey-Wicker Congressional amendment prohibits federal funding of research using human embryos.
1998 - Isolation of Human Embryonic Stem Cells (Thomson).

1999 - DHHS announced decision to fund research using Human ES cells derived as a byproduct of IVF treatments.

2001 - House of Representatives Weldon-Stupak Bill prohibits ALL human cloning, includes creation of embryo for ES cells or as fertility treatment. Criminal penalties. Failed in U.S. Senate.

2001 - President announced his decision to allow Federal funds to be used for research on existing registered human embryonic stem cell lines.

NIH Human Embryonic Stem Cell Registry

http://escr.nih.gov/ Registry of stem cell lines that comply with Federal NIH research grant requirements :

The derivation process (which commences with the removal of the inner cell mass from the blastocyst) had already been initiated by 8/9/01.

The embryo from which the stem cell line was derived no longer had the possibility of development as a human being.
The President also established the following criteria that must be met:

The stem cells must have been derived from an embryo that was created for reproductive purposes;

The embryo was no longer needed for these purposes;

Informed consent must have been obtained for the donation of the embryo;

No financial inducements were provided for donation of the embryo.

Recent Cloning/Stem Cell Legislation

Late 2002, Clonaid announced they had cloned a human an raised concerns.
2002 - UN proposal to ban Reproductive Cloning, blocked by U.S. advocates of total ban on cloning.

2003 - House of Representatives. Human Cloning Prohibition Act passed to ban human cloning for any purposes including therapeutic stem cell creation. Criminal penalties…fines and jail term.

2003 - Senate yet to pass one of a couple of proposals.

48 Bills making their way through 22 State legislatures to address the issue of cloning/ES cells in the absence of any definitive legislation by U.S.

Stem Cell Ethical Gradations

Ethical Distinctions being made between:
1. Adult Stem Cells - derived from adult tissues and genetically identical to donor.

2. Embryonic Stem Cell Lines - cell lines originally derived from IVF embryos prior to 8/01 and propagated in vitro. Available through the NIH register.

3. Embryonic Stem Cell - cell lines derived from newly donated IVF embryos. Stem cells are harvested from the embryo in early stage.

4. Therapeutic ES Cloning - transfer of the nuclear DNA material from a patient's cell into a donor egg cell to create an embryo from which embryonic stem cells can be harvested.

5. Reproductive Cloning - To create a viable human embryo and live birth.

Ethical Concerns

1. Is it ethical to "harvest" embryonic stem cells? What is the legal and moral status of a human embryo at the blastocyst state?

Genetically human - any use devalues humanity. Any dates used to establish as separate legal entity are arbitrary.

Does not contain any characteristics of a person, is not conscious/self aware, only a cluster of cells.

Embryonic Cells from IVF clinics would otherwise be destroyed, donated to another family or donated to research. Is active destruction of embryo worse than letting it die?

2. Who has the right to give consent for the embryo?

Parents?

Courts?

Currently, parents can choose to donate their child's organs or decide to take them off of life support systems.

Therapeutic ES cells have same genetics as the donor and would be derived from the donor for the donor's benefit. Do they have ownership…how does this compare with our patent law?

3. What alternatives are available which would be less objectionable and possibly more effective?

Should we use only ES cell lines already established?

Should research using adult stem cells be encouraged?

Should banking of umbilical cord stem cells be encouraged?

Do we know enough about adult vs. embryonic stem cells to decide at this point without doing further research?

4. Is Government funding for ES cell research ok if morally offensive to citizens?

Does this same claim follow for other government activities that citizens find offensive? (War, abortion, capital punishment)

5. Is a Government ban on research that could be beneficial to many citizens ethical?

Benefits to over 130 million people in U.S.

Stem Cell Research. Understanding complex events that occur during human development and normal/abnormal cell growth.

Drug Testing and research on impacts and effectiveness of new drugs. Stem Cell Therapy.

Regenerative therapies for many incurable conditions (Parkinson's, Diabetes, Kidney disease).

6. Does a Government ban on research open the door for uncontrolled use of ES?

Federal oversight would provide assurances that the acquisition of discarded embryos takes place with respect and donor consent.

Stanford University recently announced that they were the beneficiary of a $12 Million grant from an annonymous donor to form an institute to research ES cells. No Federal grants will be requested.

NIH provides $27.3 Billion in grants for Biomedical Research annually.

Other Concerns

What if the ES Cell cells used in therapy start to grow uncontrollably? Safety of process. Researching with suicide genes.

Correctly synchronizing functioning of entire genome in ES Cell to eliminate problems.. As in premature aging of Dolly.

Resources:

Stem Cells and Cloning. David A. Prentice, Indiana State University. Benjamin Cummings 2003

Department of Health and Human Services, National Institutes of Health Human Embryonic Stem Cell Registry, last updated 11/2002, http://escr.nih.gov/

National Institutes of Health, "Stem Cells: A Primer", September 2002, http://www.nih.gov/news/stemcell/primer.htm

Remarks by the President on Stem Cell Research, President George W. Bush, 8/9/2001, http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html

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Updated 4/7/03 by thatcher@sonoma.edu

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	Presentation on Stem Cell Research 4/2/03 Stem Cell Legislation & Ethics Karen Early Stem Cell Legislation 1996 - Dickey-Wicker Congressional amendment prohibits federal funding of research using human embryos. 1998 - Isolation of Human Embryonic Stem Cells (Thomson). 1999 - DHHS announced decision to fund research using Human ES cells derived as a byproduct of IVF treatments. 2001 - House of Representatives Weldon-Stupak Bill prohibits ALL human cloning, includes creation of embryo for ES cells or as fertility treatment. Criminal penalties. Failed in U.S. Senate. 2001 - President announced his decision to allow Federal funds to be used for research on existing registered human embryonic stem cell lines. NIH Human Embryonic Stem Cell Registry http://escr.nih.gov/ Registry of stem cell lines that comply with Federal NIH research grant requirements : The derivation process (which commences with the removal of the inner cell mass from the blastocyst) had already been initiated by 8/9/01. The embryo from which the stem cell line was derived no longer had the possibility of development as a human being. The President also established the following criteria that must be met: The stem cells must have been derived from an embryo that was created for reproductive purposes; The embryo was no longer needed for these purposes; Informed consent must have been obtained for the donation of the embryo; No financial inducements were provided for donation of the embryo. Recent Cloning/Stem Cell Legislation Late 2002, Clonaid announced they had cloned a human an raised concerns. 2002 - UN proposal to ban Reproductive Cloning, blocked by U.S. advocates of total ban on cloning. 2003 - House of Representatives. Human Cloning Prohibition Act passed to ban human cloning for any purposes including therapeutic stem cell creation. Criminal penalties…fines and jail term. 2003 - Senate yet to pass one of a couple of proposals. 48 Bills making their way through 22 State legislatures to address the issue of cloning/ES cells in the absence of any definitive legislation by U.S. Stem Cell Ethical Gradations Ethical Distinctions being made between: 1. Adult Stem Cells - derived from adult tissues and genetically identical to donor. 2. Embryonic Stem Cell Lines - cell lines originally derived from IVF embryos prior to 8/01 and propagated in vitro. Available through the NIH register. 3. Embryonic Stem Cell - cell lines derived from newly donated IVF embryos. Stem cells are harvested from the embryo in early stage. 4. Therapeutic ES Cloning - transfer of the nuclear DNA material from a patient's cell into a donor egg cell to create an embryo from which embryonic stem cells can be harvested. 5. Reproductive Cloning - To create a viable human embryo and live birth. Ethical Concerns 1. Is it ethical to "harvest" embryonic stem cells? What is the legal and moral status of a human embryo at the blastocyst state? Genetically human - any use devalues humanity. Any dates used to establish as separate legal entity are arbitrary. Does not contain any characteristics of a person, is not conscious/self aware, only a cluster of cells. Embryonic Cells from IVF clinics would otherwise be destroyed, donated to another family or donated to research. Is active destruction of embryo worse than letting it die? 2. Who has the right to give consent for the embryo? Parents? Courts? Currently, parents can choose to donate their child's organs or decide to take them off of life support systems. Therapeutic ES cells have same genetics as the donor and would be derived from the donor for the donor's benefit. Do they have ownership…how does this compare with our patent law? 3. What alternatives are available which would be less objectionable and possibly more effective? Should we use only ES cell lines already established? Should research using adult stem cells be encouraged? Should banking of umbilical cord stem cells be encouraged? Do we know enough about adult vs. embryonic stem cells to decide at this point without doing further research? 4. Is Government funding for ES cell research ok if morally offensive to citizens? Does this same claim follow for other government activities that citizens find offensive? (War, abortion, capital punishment) 5. Is a Government ban on research that could be beneficial to many citizens ethical? Benefits to over 130 million people in U.S. Stem Cell Research. Understanding complex events that occur during human development and normal/abnormal cell growth. Drug Testing and research on impacts and effectiveness of new drugs. Stem Cell Therapy. Regenerative therapies for many incurable conditions (Parkinson's, Diabetes, Kidney disease). 6. Does a Government ban on research open the door for uncontrolled use of ES? Federal oversight would provide assurances that the acquisition of discarded embryos takes place with respect and donor consent. Stanford University recently announced that they were the beneficiary of a $12 Million grant from an annonymous donor to form an institute to research ES cells. No Federal grants will be requested. NIH provides $27.3 Billion in grants for Biomedical Research annually. Other Concerns What if the ES Cell cells used in therapy start to grow uncontrollably? Safety of process. Researching with suicide genes. Correctly synchronizing functioning of entire genome in ES Cell to eliminate problems.. As in premature aging of Dolly. Resources: Stem Cells and Cloning. David A. Prentice, Indiana State University. Benjamin Cummings 2003 Department of Health and Human Services, National Institutes of Health Human Embryonic Stem Cell Registry, last updated 11/2002, http://escr.nih.gov/ National Institutes of Health, "Stem Cells: A Primer", September 2002, http://www.nih.gov/news/stemcell/primer.htm Remarks by the President on Stem Cell Research, President George W. Bush, 8/9/2001, http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html ..

Biotechnology Presentations

Presentation on Stem Cell Research 4/2/03